SUPPLY CHAIN ARTICLES
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![coronavirus covid-GettyImages-1220020527]( "FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities")
FDA Sets Recommendations For Predicting Dangerous Nitrosamine ImpuritiesThe FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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![Business Unity-GettyImages-1253212054]( "The RNA Therapeutics Supply Chain: A Platform of Relationships")
The RNA Therapeutics Supply Chain: A Platform of RelationshipsConversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
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![Cell transfection with plasmid GettyImages-1290924802]( "Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why")
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's WhyThe demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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![Man working in vegetable garden-GettyImages-1327986655]( "Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions")
Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future DirectionsOverall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
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![iStock-1095134748]( "Therapeutic Oligonucleotides: Regulations & Quality Standards")
Therapeutic Oligonucleotides: Regulations & Quality StandardsOligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
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![women gossiping-GettyImages-72131155]( "A \"Hot Take\" on Personalized mRNA Medicines")
A "Hot Take" on Personalized mRNA MedicinesmRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
SUPPLY CHAIN VIDEOS
In this Bioprocess Online Live panel, we discuss two experts' perspectives on the current state of the mRNA supply chain for critical raw materials and manufacturing supplies and where pain points still exist.
Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.
Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 3, Welch explores the similarities that exist between the art of crafting a high quality violin and the upstream process development work mRNA therapeutics experts are performing today to create the most ideal mRNA drug substance.
In this Advancing RNA Live clip, CPI’s Claire MacCleod shares the biological and logistical hurdles currently keeping full enzymatic production of siRNA at bay.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Cryoport]( "Accelerate Your Trials With An End‑To‑End Supply Chain Model")
An end-to-end supply chain model helps clinical trials move faster while maintaining visibility, control, and risk management across complex, temperature‑sensitive, and global operations.
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![Advancing RNA_Primrose Scientific Poster]( "Advancing mRNA Therapeutics With High Performance RNA Polymerases")
Learn how optimized RNA polymerases enhance mRNA therapeutic quality and transcript integrity by increasing yield and capping efficiency while reducing double-stranded RNA impurities.
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![GettyImages-1387090964 cell and gene therapy]( "Gene And Cell Therapy: Planning For Manufacturing Success Early")
As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
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![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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![GettyImages-2183428951-biomanufacturing]( "The Evolution Of Nucleotide Production")
From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
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![iStock-1222894162-vaccine-lab-PPE]( "mRNA Vaccine Development: Planning, Workflow, Supply Chain Success")
A review of insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of vaccines and therapeutics moving forward.
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
